Compositions and Methods for Treating Female Sexual Dysfunction

Abstract

This invention relates to methods, pharmaceutical compositions and kits useful in treating female sexual dysfunction and the use of an estrogen agonist/antagonist for the manufacture of a medicament for the treatment of female sexual dysfunction. The compositions are comprised of an estrogen agonist/antagonist as a first active ingredient and a cyclic guanosine 3′,5′-monophosphate elevator as a second active component and a pharmaceutically acceptable vehicle, carrier or diluent. The compositions and methods of treatment are effective while substantially reducing the concomitant liability of adverse effects associated with estrogen administration.

1 .- 34 . (canceled) 
     
     
         35 . A method for treating female sexual arousal disorder, hypoactive sexual desire disorder or orgasmic disorder comprising:
 orally administering to a female subject in need thereof, an effective amount of (−)-cis-6-phenyl-5-[4-(2-pyrrolidin-1-yl-ethoxy)-phenyl]-5,6,7,8-tetrahydro-naphthalene-2-ol or a pharmaceutically acceptable salt thereof and further optionally comprising orally co-administering an effective amount of a cyclic guanosine 3′,5′-monophosphate elevator.   
     
     
         36 . The method of  claim 35  wherein the cyclic guanosine 3′,5′-monophosphate elevator is administered and is a PDE V  phosphodiesterase inhibitor. 
     
     
         37 . The method of  claim 36  wherein the PDE V  phosphodiesterase inhibitor is 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5yl)-4-ethoxy-phenyl]sufonyl]-4-methylpiperazine citrate salt. 
     
     
         38 . The method of  claim 35  wherein (−)-cis-6-phenyl-5-[4-(2-pyrrolidin-1-yl-ethoxy)-phenyl]-5,6,7,8-tetrahydro-naphthalene-2-ol, D-tartrate salt is administered. 
     
     
         39 . A method for treating female sexual arousal disorder, hypoactive sexual desire disorder or orgasmic disorder comprising:
 orally administering to a female subject in need thereof, an effective amount of (−)-cis-6-phenyl-5-[4-(2-pyrrolidin-1-yl-ethoxy)-phenyl]-5,6,7,8-tetrahydro-naphthalene-2-ol or a pharmaceutically acceptable salt thereof.   
     
     
         40 . The method of  claim 39  wherein the female subject is pre-menopausal. 
     
     
         41 . The method of  claim 39  wherein the female subject is postmenopausal. 
     
     
         42 . The method of  claim 39  wherein the female subject is pre-menopausal. 
     
     
         43 . The method of  claim 39  wherein the (−)-cis-6-phenyl-5-[4-(2-pyrrolidin-1-yl-ethoxy)-phenyl]-5,6,7,8-tetrahydro-naphthalene-2-ol is in the form of its D-tartrate salt.